Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas in Pediatric Patients
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor
lysate-pulsed dendritic cells after surgical resection in pediatric patients with
malignant glioma.
- Determine the maximum tolerated dose of this vaccine in these patients.
Secondary
- Determine, preliminarily, the survival of patients treated with this vaccine.
- Determine, preliminarily, the time to tumor progression in patients treated with this
vaccine.
- Determine cellular immune response in patients treated with this vaccine.
- Determine age-dependent differences in response to this vaccine, in terms of
immunocompetence, in these patients.
OUTLINE: This is a dose-escalation study.
Patients undergo surgical resection to obtain tumor tissue for production of tumor lysate.
Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC) for
generation of dendritic cells (DC). DC are pulsed with tumor lysate to produce an autologous
dendritic cell vaccine. Approximately 10-30 days after leukapheresis, patients receive
vaccination with autologous tumor lysate-pulsed dendritic cells intradermally on days 0, 14,
and 28 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vaccine until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 2 weeks and then every 2
months for 1 year.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 2-4.5
years.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.
1 year
Yes
Joseph L. Lasky, MD
Principal Investigator
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
CDR0000420930
NCT00107185
January 2005
March 2010
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |